Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the months of August, September and October.
Among the new applications to be reviewed is Freyr’s new application for liraglutide (Lobezyl®). This follows TGA acceptance of Cipla’s liraglutide for review in October 2023 and Sun Pharma’s in January 2024. Novo Nordisk’s Saxenda® (liraglutide) was approved in Australia in 2015 for weight management.
Meanwhile, an application for a new indication for Novo Nordisk’s Ozempic® (semaglutide), for reducing risk of kidney failure, was accepted for review in September 2024.
Applications for new indications for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) have also been accepted for review (in October and September 2024, respectively), for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.
AstraZeneca has two applications for expanded indications under review: Imfinzi® (durvalumab) for the treatment of patients with limited-stage small cell lung cancer; and Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with metastatic NSCLC or NSCLC that cannot be removed surgically.
Other applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:
- Janssen’s Tremfya® (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn’s disease;
- Eli Lilly’s Omvoh® (mirikizumab) for the treatment of ulcerative colitis in adults who have not benefited from conventional treatments; and
- Roche’s Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.